NVO to Launch Victoza in Japan - Analyst Blog

Denmark-based Novo Nordisk (NVO) announced recently that it will launch Victoza (liraglutide), a once-daily injection for treating type II diabetes in adults, in Japan later this month.
 
The decision follows the approval regarding the price of Victoza from Japan’s Central Social Insurance Medical Council (Chuikyo). The council assists and advises the Ministry of Health, Labour and Welfare (MHLW) in deciding reimbursement classification and pricing. The MHLW is responsible for ensuring good living standards and promoting new health programs for improving the lives of the Japanese people.

The drug will be launched in Japan after Victoza is officially posted on Japan’s National Health Insurance price list on June 11. The MHLW approved Novo Nordisk’s diabetes treatment on January 20, 2010. The approval was based on a development program specifically tailored to treat Japanese patients suffering from type II diabetes.

Victoza is the first human glucagon-like peptide-1 (GLP-1) analogue to hit the Japanese market. The drug aims at improving glycemic control in combination with metformin or metformin and a sulfonylurea. Glycemic control refers to the levels of blood sugar (glucose) in a person suffering from diabetes mellitus.

Last month the drug was approved in Canada. Earlier this year, the US Food and Drug Administration (FDA) approved Victoza for the treatment of type II diabetes in adults. The drug was approved for use with proper diet, exercise and other diabetes medicines for lowering blood sugar levels. However, the FDA did not recommend Victoza as an initial therapy in patients who could not control diabetes with diet and exercise alone.

In addition to existing competition, Victoza might face competition from candidates currently under development or regulatory review. A potential competitor could be Bydureon, a GLP-1 molecule, co-developed by Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Co. (LLY) and Alkermes, Inc. (ALKS). The FDA will decide on Bydureon later in the year (target date: Oct 22, 2010). Other GLP-1 molecules under development include GlaxoSmithKline’s (GSK) Syncria (albiglutide) and Roche (RHHBY)/Ipsen’s taspoglutide.
 
Novo Nordisk is a key player in the insulin and diabetes care markets globally. Furthermore, the company manufactures and markets a variety of other pharmaceutical products. Novo Nordisk is the largest producer of industrial enzyme products across the globe.